
USFDA APPLICATION NUMBER - 207145 / DOSAGE - TABLET;ORAL - EQ 50MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| SAFINAMIDE MESYLATE(UNII: YS90V3DTX0) (SAFINAMIDE - UNII:90ENL74SIG) | SAFINAMIDE | 50mg | 100mg |
Inactive Ingredients
| Ingredient Name | Catalent Germany Schorndorf GmbH |
|---|---|
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| MICA(V8A1AW0880) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |